Home » MedAlliance’s SELUTION SLR drug-eluting balloon (DEB) receives FDA investigational device exemption (IDE) approval, making it the first limus DEB to be available to US patients

MedAlliance’s SELUTION SLR drug-eluting balloon (DEB) receives FDA investigational device exemption (IDE) approval, making it the first limus DEB to be available to US patients

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Geneva, May 26, 2022 / CNW /-SELUTION SLR (Sustained Limus Release) is a new sirolimus-eluting balloon that provides controlled and sustained drug release, similar to drug-eluting stents (DES). SELUTION SLR is also the first DEB (drug-eluting balloon) to be given a “breakthrough device designation” by the FDA. March 4, 2019 And even more September 25, 2019 Below-the-knee (BTK) indications for peripheral arterial disease.

The MedAlliance SELUTION SLR Drug Elution Balloon (DEB) has been approved by the FDA for clinical trial device exemption (IDE) and is the first Limus DEB available to patients in the United States (PRNewsfoto / MedAlliance).

This is a major milestone in the Med Alliance. We have successfully completed the bench and preclinical trials required by the FDA and are ready to enroll US patients in clinical trials to support the submission of FDAPMA approvals. Jeffrey B. Jump Medal Alliance Chairman and CEO is pleased that patients in the United States can also benefit from this “breakthrough technology.”

MedAlliance Begins Enrollment in Under-Knee (BTK) IDE Randomized Controlled Trials (RCTs) SELUTION4BTK (ClinicalTrials.gov Identifier: NCT05055297) Outside the United States (OUS) and at a US center earlier this summer.The main researchers in the study are doctors Erin Armstrong (we), Marian Brodmann ((((Austria), When Tjun Tang ((((Singapore).

SELUTION SLR received CE Mark approval for the treatment of peripheral arterial disease in February 2020. This device has early and promising clinical results in the treatment of patients with chronic limb threatening ischemia (CLTI) and subknee artery disease.In the PRESTIGE study presented by Dr. as a late exam at the VIVA 2021 conference Tjun TangThe use of SELUTION SLR in complex BTK lesions has resulted in sustained safety and efficacy up to 18 months. An additional 75 patients treated with BTK disease and SELUTION SLR will be studied in the PRISTINE registry and the results will be published in LINC 2022. Based on early promising data after using SELUTION SLR to treat BTK disease, the Med Alliance proceeded with the design of the SELUTION 4 BTK RCT to further investigate the safety and efficacy of this device and prepare for FDA approval. ..

SELUTION SLR technology includes a unique microreservoir made from a mixture of biodegradable polymer and the anti-restenosis drug sirolimus. These Micro Reservoirs provide controlled and sustained release of Limus (SLR) of the drug. Sustained release of sirolimus from the stent has been demonstrated to be very effective in both the coronary and peripheral vasculature. MedAlliance’s proprietary CAT ™ (Cell Adherent Technology) allows MicroReservoirs to be coated on a balloon and adhered to the vascular lumen when delivered via an angioplasty balloon.
SELUTION SLR is available at Europe And all other countries where the CE mark is recognized.

contact:
Richard Kennion
[email protected]
+44 7831 569940

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MedAlliance logo (PRNewsfoto / MedAlliance)

MedAlliance logo (PRNewsfoto / MedAlliance)

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